Kornimate/medical-research-clean huggingface dataset:
fish oil (omega 3 ) in sjogren's syndrome

Conditions: Sjogren's Syndrome

Summary: sjögren's syndrome (pss) is an autoimmune disorder affecting mainly the exocrine glands.this lead to dryness of the main mucosal surface ,such as the mouth ,eye,skin nose,pharynx,larynx and vagina . the history of the disease is characterized by a slowly progression of sicca symptoms and fatigue; however, a subset of patients would experience extra glandular activity. lipid mediators derived from polyunsaturated fatty acids, related to inflammation and immune response regulation. in this sense, the polyunsaturated fatty acids omega-3 (ω-3 fa) have been associated with several illnesses such as cancer, cardiovascular disease and autoimmune diseases and their balance at the cellular membranes can result in an anti-inflammatory .

this is a randomized double -blind placebo -controlled clinical trial .the participants will be randomize into two groups .group 1 receive dietary omega-3 supplementation (omega-3 group) whereas group 2(placebo group) receive a placebo . the two types are similar to each other in the form of soft gel ,both are given two times daily for two months with follow-up of patients whom they full fill the inclusion criteria.

Eligibility criteria:
inclusion criteria: * age≥ 18 and ≤ 70 years old . * able to provide inform consent * patients diagnosed as syndrome according to 2016 acr(american college of rheumatology)/ eular(european league against rheumatism classification criteria for sjögren's syndrome exclusion criteria: * any preexisting ocular disease or on eye drops lubricants. * patients on (beta blockers, diuretics , anticholinergic, α 1antagonist and α 2 agonist ,anticoagulant, antidepressant, antihistamine ,pilocarpine, cevimeline ) . * past history of diabetes, psychiatric disorder. * pregnancy, lactating mother * malignancy

Keywords: sjogren's syndrome omega 3 fatty acid dry eye dry mouth
adolescent changes in brain and behavior in boys and girls with adhd

Conditions: ADHD; Attention Deficit Hyperactivity Disorder

Summary: the purpose of the study is to examine the developmental trajectory of response control in boys and girls with adhd entering adolescence. the investigators also want to determine the developmental trajectory of brain anatomy and brain connectivity in boys and girls with adhd entering adolescence.

children with attention deficit hyperactivity disorder (adhd) are at risk for a host of deleterious outcomes including impaired social relations, academic difficulties, criminality, and comorbid psychopathology (substance use, depression, anxiety). many of these difficulties emerge and exacerbate during adolescence; therefore, it is crucial to understand the developmental trajectory of adhd-associated changes in brain and behavior during this sensitive period. further, there is increasing recognition that sex may be an important moderator of the clinical manifestations of adhd, with adolescent boys showing more impulsive risk-taking while girls show more emotional dysregulation. identification of patterns of brain and behavioral development associated with risk for poor outcome in both boys and girls with adhd shows the profound public health significance of our research. furthermore, the investigators are proposing to examine the dimensional construct of response control in children with adhd from multiple levels of analysis including neural structure and connectivity, behavioral expression, and relation to functional outcomes, with the ultimate goal of identifying bio-behavioral markers of impairment and adjustment in children with adhd. our objectives: aim 1: to examine the developmental trajectory of response control in boys and girls with adhd entering adolescence. aim 2: to examine how baseline abnormalities in response control and brain structure and function, as well as development trajectories for these measures, differentially predict functional outcomes in adolescent boys and girls with adhd. aim 3: to examine how intrinsic functional connectivity relates to brain structure, structural connectivity, and response control in adolescent boys and girls with adhd.

Eligibility criteria:
inclusion criteria: * diagnosed with or without attention deficit hyperactivity disorder * must be able to attend a follow-up after 18 months after initial visit exclusion criteria: * diagnosed with autism spectrum disorder (asd) * diagnosed with schizophrenia, conduct disorder, and/or bipolar disorder * diagnosed with a genetic disorder * premature birth (less than 36 weeks)

Keywords: cognitive testing typically developing motor control gender differences
evaluation of weekly tafenoquine

Conditions: Malaria

Summary: this study is a phase 2b, placebo controlled, randomized, blinded study of the efficacy of wr 238605, a new primaquine analog, compared to placebo as chemosuppression of p. falciparum malaria in nyanza province, western kenya.


Eligibility criteria:
inclusion criteria: 1. healthy subjects (male or female) 2. age of 18-55 years 3. residing in one of the study villages of the nyanza province for the entire study exclusion criteria: 1. any cardiovascular, liver, neurologic, or renal functional abnormality which in the opinion of the clinical investigators would place the subject at increased risk of an adverse event or confuse the result. 2. female subjects who were pregnant (positive serum / plasma -hcg as tested within 48 hours of first drug administration). 3. use of antimalarial drugs not prescribed by study physicians within 2 weeks of study drug initiation. 4. clinically significant abnormalities (including but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and complete blood count. 5. known hypersensitivity to any study drug. 6. unwilling to remain in area and report for drug administration and blood drawing during the duration of the study. 7. glucose 6 phosphate dehydrogenase (g6pd) deficiency.
study of the relative abuse potential of acurox tablets in non-dependent recreational opioid users

Conditions: Opioid Abuse

Summary: the primary objective of this study is to compare the relative abuse potential of two different doses of orally administered acurox tablets to orally administered immediate-release (ir) oxycodone hcl tablets in non-dependent recreational opioid users.

in the tretament phase, 5 treatments administered were oxycodone hcl/niacin tablets as follows: (a) 40/0 mg, (b) 80/0 mg, (c) (40/240 mg, (d) 80/480 mg and (e) 0/0 mg. each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. all doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. doses were separated by 48 (± 1) hours. all subjects received each treatment in a randomized sequence using a williams design.

Eligibility criteria:
inclusion criteria: * subject is male or female between 18 and 55 years old. * subject is in generally good health, including no history of pulmonary disease, and has a body mass index (bmi) within 18-33 kg/m2. * subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 months, and at least 1 within the past 12 weeks) who is not physically dependent on opioids (per diagnostic and statistical manual of mental disorders-fourth edition-text revision \[dsm-iv-tr\]); is able to speak, read, and understand english; and will provide written informed consent. * subject has a minimum of a 6th grade reading level as determined by the investigator or by the rapid estimation of adult literacy in medicine (realm). exclusion criteria: * history or current diagnosis of substance dependence (except nicotine and caffeine) and/or alcohol abuse according to the criteria of dsm-iv-tr. * history or current diagnosis of neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease. * known allergy or history of hypersensitivity to oxycodone hcl, other opioids, or any component of acurox tablets.

Keywords: abuse liability abuse prevention abuse resistance abuse deterrence
phase i study to assess the absorption, metabolism, and excretion of [14c] labeled spn-810m

Conditions: Impulsive Aggression Comorbid With ADHD

Summary: an open-label, single-dose, mass-balance study to assess the absorption, metabolism, and excretion of radio labeled spn-810m in healthy adult male volunteers


Eligibility criteria:
key entry: 1. healthy males. 2. aged 30 to 55 years. 3. considered medically healthy by the investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram. 4. able to voluntarily provide written informed consent to participate in the study.

Keywords: impulsive aggression adhd
evaluate esophageal reinforcement with acell matristem surgical matrix: a degradable biologic scaffold material

Conditions: Esophageal Adenocarcinoma

Summary: the purpose of this study is to see if implanting matristem will lower the risk of one of the more common complications after stomach or esophagus surgery.


Eligibility criteria:
inclusion criteria: * patient 18 years of age or older * pathologically confirmed gastric, gastroesophageal junction (gej) or esophageal, adenocarcinoma at either mskcc or a participating site (biopsy may be performed at other institutions but slides must be confirmed at mskcc or a participating site, as is routine care at our institution) * patient undergoing any resection requiring an anastomosis to the esophagus for curative intent. including but not limited to esophagectomy or total gastrectomy. * subject is willing to provide written informed consent * subject is willing and able to comply with the follow-up regimen exclusion criteria: * pregnant or lactating women * intraoperative evidence of metastatic or locally-unresectable disease * patients with known sensitivity or allergy to porcine materials. * patients undergoing any resection requiring an anastomosis to the esophagus for palliative intent.

Keywords: esophageal reinforcement acell matristem 13-178
safe (sarpogrelate anplone in femoro-popliteal artery intervention efficacy) study

Conditions: Peripheral Arterial Disease

Summary: after endovascular treatment (evt) for peripheral artery disease (pad), dual antiplatelet therapy (daat) of aspirin (asa) and clopidogrel are currently drug of choice to prevent occlusion. anplone sr®, controlled-released sarpogrelate hydrochloride, has been introduced as an anti-platelet agent for the drug of pad. the aim of this study was to compare the efficacy and safety of anplone + aspirin and clopidogrel + aspirin in patients who underwent evt for femoro-popliteal occlusive disease.


Eligibility criteria:
inclusion criteria: 1. adult, \>18 years old 2. angiographically-confirmed significant femoro-popliteal (fp) stenosis or occlusion by atherosclerosis 3. successful fp intervention; residual stenosis \<30% 4. without significant residual inflow disease; intact iliac artery inflow (with or without intervention of iliac or below knee arteries) 5. patent outflow status; at least 1 arterial runoff in below knee arteries 6. all kind of fem-pop intervention including poba, stent, dcb, des for tasc a\~ d exclusion criteria: 1. at risk of hemorrhage, bleeding tendency or thrombophilia 2. acute limb ischemia / inflammatory arterial disease 3. contraindication or allergic to asa, clopidogrel, anplone 4. medication of warfarin 5. pregnancy, hepatic dysfunction, thrombocytopenia 6. previous fp bypass or intervention 7. impossible to stop clopidogrel before evt
turmeric based therapy in the treatment of psoriasis: a clinical trial

Conditions: Psoriasis

Summary: psoriasis affects around 4% of world population. the disease could be disabling and disfiguring dermatologic condition. world health organization (who) has recently drawn the attention to the inadequate treatment options psoriasis patients suffer from among other problems. furthermore, the available treatment options have many side effects. a lot of the effective treatment options are either expensive or not appropriate for hepatic patients who represent a large subset of egyptian psoriatic patients. this highlights the need for inexpensive and safe alternative. the effectiveness of turmeric in psoriasis treatment have been addressed in few reports. having an immune modulatory effect especially as anti nfκb it is expected to be effective therapy with minimal side effect. up to the investigator's knowledge this is the first study addressing the efficacy of combined turmeric and olive oil based topical therapy in psoriasis treatment

psoriasis is a prevalent skin disorder. it affects around 4% of world's population. it can be disfiguring and disabling in severe cases. there is dysregulated immune response in psoriatic patients to unknown injurious agents with upregulation of th1/th17 pathways which is mediated via nuclear factor kappa b (nfκb). nfκb is a key player in psoriasis development; its activation and nuclear translocation is present in every step of the way of psoriasis starting from keratinocyte release of cytokines -in response to stress- to the maturation and activation of dendritic cells, to the continuous loop of t cell activation. turmeric extract has anti-inflammatory, anti-oxidant, anti-microbial and anti-carcinogenic effects. it has inhibitory effects on nf-κb and various cytokines production. in this clinical trial 5 groups of patients with mild to moderate psoriasis are recruited; group (a) receiving the turmeric extract based ointment only. group (b) receiving turmeric extract + olive oil based treatment. group (c) will serve as negative control receiving only petrolatum base. group (d) will receive nb uvb serving as positive control. group (e) will receive established topical treatment serving as positive control. each patient will be assessed on weekly bases clinically for the disease severity using pasi score and via dermatoscope. histopathological evaluation (h\& e along with nfkb expression analysis) will be done at 4 points of time baseline, 4 weeks, 8 weeks, 12 weeks through the study.

Eligibility criteria:
inclusion criteria: 1. patients with mild to moderate psoriasis vulgaris of any age \& gender. 2. patient didn't receive any systemic or topical therapy for psoriasis the last 4 weeks. exclusion criteria: 1. patients previously received topical or systemic therapy for psoriasis in the past 4 weeks. 2. patients with pustular or erythrodermic psoriasis. 3. patients with other dermatological diseases. 4. patients have hypersensitivity from the active ingredients of the therapy.

Keywords: psoriasis turmeric curcumin olive oil dermoscopy nfkb
safety and efficacy of technosphere® insulin inhalation powder (ti inhalation powder)when an optimal dose is taken with varied carbohydrate intake

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Summary: the purpose of this study is to determine if, once a favorable dose of ti inhalation powder is established for either a type 1 or 2 patient, based on a average diabetic meal, the patient's favorable dose can be used safely, regardless of change in meal carbohydrate content. patients were randomly assigned to various carbohydrate loads (0%, 50%, 100%, 150% or 200%). the 100% carbohydrate load was determined based upon their standard insulin dose for their normal meal.


Eligibility criteria:
inclusion criteria: * clinical diagnoses of type 1 or type 2 diabetes mellitus * fasting plasma glucose (fpg) 80, 140 mg/dl and glycated hemoglobin (a1c) \> 6.5% and \< or = 10.0%. * body mass index (bmi) of \< or = 40 kg/m2 * non-smokers (never smoked or former smokers \[= 6 months since cessation\]) and a urine cotinine level \< or = 100 ng/dl * forced expiratory volume in 1 second (fev1) = 70% third national health and nutrition examination survey (nhanes iii) predicted; pre-bronchodilator fev1 as a percentage of forced vital capacity (fev1/forced vital capacity(fvc)) = 70% * for subjects with type 2 diabetes mellitus: currently receiving oral diabetic treatment or basal insulin +/- oral diabetic treatment exclusion criteria: * history of chronic obstructive pulmonary disease (copd), clinically proven asthma, and/or any other clinically important pulmonary disease confirmed by pulmonary function test (pft) and/or radiologic findings * elevated liver function test (alanine aminotransferase \[alt\] or aspartate aminotransferase \[ast\] \> 3 times the normal reference range or bilirubin \> 1.5 times the reference range) * previous use of exubera; use of symlin (pramlintide acetate) and/or byetta (exenatide) within the past 12 weeks * unstable diabetes control and evidence of severe complications of diabetes mellitus (ie, autonomic neuropathy) * exposure to any investigational product(s) in the past 12 weeks * for subjects with type 2 diabetes mellitus: in subjects taking metformin, serum creatinine \> 1.4 mg/dl in female subjects and \> 1.5 mg/dl in male subjects
velcade combined with high-dose dexamethasone in patients with newly diagnosed multiple myeloma

Conditions: Multiple Myeloma

Summary: the objective of this study is to evaluate the efficacy and safety of velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.


Eligibility criteria:
inclusion criteria: * diagnosis of mm according to the swog criteria (annex 1) * previously untreated (localized radiotherapy is allowed) * symptomatic mm stage ii or iii according to durie-salmon staging system (annex 2) or stage i with one symptomatic osteolytic lesion * with measurable levels of paraprotein in the serum (\> 1g/dl) or in the urine (\> 0.2g/24h) * age \< 75 years * able to understand and to given an informed consent * male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. women of childbearing potential must be following adequate contraceptive measures. * no active systemic infection. in the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with velcade plus dexamethasone. exclusion criteria: * life expectancy \< 2 months * ecog performance status \> 2 (annex 3) * proven amyloidosis * positive hiv serology * antecedents of severe psychiatric disease * severe diabetes contraindicating the use of high-dose corticoïds * \> nci grade 2 peripheral neuropathy (annex iv) * serum biochemical values as follow * creatinin level \> 200mmol/l * bilirubin, transaminases or ggt \> 3 the upper normal limit * use of any experimental drugs within 30 days of baseline

Keywords: the efficacy and safety of velcade plus dexamethasone multiple myeloma
study to determine the dose of recombinant human hyaluronidase needed to infuse a full dose of igiv subcutaneously

Conditions: Primary Immunodeficiency Diseases (PID)

Summary: the purpose of the study is to determine the feasibility of infusing a full 4-week dose of immune globulin intravenous (human), 10% in a single subcutaneous site and the amount of recombinant human hyaluronidase needed to infuse that dose with no more than mild local adverse drug reactions.


Eligibility criteria:
inclusion criteria: * written informed consent from either the subject or the subject's legally acceptable representative * diagnosis of a pid disorder as defined by world health organization criteria1 for which the subject had been receiving a regimen of weekly or biweekly (every-other-week) subcutaneous igg infusions or igiv infusions every 21 to 28 days over a period of at least 8 weeks pre-study at an equivalent of a 4-week dose of 300 to 800 mg/kg bodyweight * adults/adolescents aged 16 years and older) * for female subjects of child-bearing age: negative urine pregnancy test result at study entry and agreement to employ adequate birth control measures for the duration of the study exclusion criteria: * subjects positive at enrollment for one or more of the following: hbsag, pcr for hcv, pcr for hiv type 1 * subjects with levels of alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2.5 times the upper limit of normal for the testing laboratory * subjects with neutropenia (defined as an absolute neutrophil count \[anc\] \<= 500/mm3). * subjects with serum creatinine levels greater than 1.5 times the upper limit of normal for age and gender * subjects with current history of malignancy * subjects with a history of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident) * subjects with abnormal protein loss (protein losing enteropathy, nephritic syndrome, severe lung disease) * subjects with anemia that in the opinion of the investigator precluded phlebotomy for laboratory studies * subjects who had been exposed to any blood or blood product other than an intravenous immunoglobulin (igiv), sc immunoglobulin (scig), immune serum globulin (isg) preparations, or albumin within the 6 months prior to study entry. * subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following igiv, scig and/or isg infusions * subjects with iga deficiency and known anti iga antibodies * subjects who had received antibiotic therapy for the treatment of infection within 7 days prior to enrollment * subjects who had participated in another clinical study involving an investigational product or device within 28 days prior to study entry * subjects with inability or unwillingness to meet all the requirements of this study * if female, pregnancy or lactation at time of study entry